Condition category
Mental and Behavioural Disorders
Date applied
28/05/2020
Date assigned
02/06/2020
Last edited
02/06/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

Plain English Summary

Background and study aims
Poor mental health in young people is increasing, with clear evidence of mounting psychiatric problems. However, less than a quarter of young people with mental health problems can access services, meaning there is an urgent need for easily accessible and effective mental health resources. Common barriers include the limited provision of services, reluctance of adolescents to seek professional help as well as a fear of stigmatisation.

Young people’s mental health is a major government priority, with current policy advocating the development of effective education based mental health care to prevent the escalation of mental health problems, improve access and reduce service waiting times. However, existing school-delivered programmes for depression and anxiety only have modest effects. These programmes are also mainly focused on younger children.

With these factors in mind, we have developed an accessible and non-stigmatising workshop program for older students. This award-winning programme, named DISCOVER, is a brief group workshop programme for 16 - 18-year-olds that was developed in collaboration with a Teenage Advisory Group (TAG) of 16 - 18-year-olds. DISCOVER aims to improve engagement, offer effective treatment, and maintain participants’ motivation and improvement to reduce relapse. The DISCOVER workshop is delivered in a group setting, to around 12 - 15 young people, over one school day. The workshop includes videos, discussions, and the chance to learn and practice techniques designed to improve and maintain mental wellbeing. The workshop material is organised into eight short (20 minute) sections and particular attention is paid to personal, relationship and academic worries typical for 16 - 18-year-olds. Specific methods taught include (i) Behavioural methods e.g. time management, sleep hygiene and maintaining motivation (ii) Cognitive methods e.g. learning to challenge negative thoughts and (iii) mindfulness e.g. meditation exercises. Following the workshop, to maintain progress and adherence, participants receive a DISCOVER workbook and access to a workshop-specific DISCOVER app to remind them of the methods. Participants also receive three 'follow-up' phone calls from the workshop leader to discuss how they are progressing with their personal goals.

We would like to understand whether this workshop is more effective at improving students’ mental health than the normal care they receive at school. Specifically, this clinical trial aims to answer the research question of whether the DISCOVER workshop is a clinically effective and cost-effective intervention in schools that reduces symptoms of depression in 16-18-year-olds at 3 and 6 months after the intervention.

The results of this trial will tell us whether DISCOVER is a suitable programme to take forward as a school-based mental health provision. It is very possible that DISCOVER could be a highly effective and popular component in frontline education-based mental health care as advocated by government health and education policy. We see DISCOVER fitting in very well with the current education-based mental health care aims of the government. Therefore, this trial is essential to inform the Department of Health about the effectiveness of this potentially very important intervention for 16 - 18-year-olds.

Who can participate?
The DISCOVER workshop is designed for sixth form/college students between 16 and 18 who are experiencing, or have experienced, stress or low mood problems recently. We hope this program will be helpful for as many people as possible from this group, however we are still assessing how effective it can be. It is not so suitable for young people who have very severe problems or who do not understand spoken and written English.

What does the study involve?
The study involves the comparison of two different intervention groups; the active intervention (the DISCOVER workshop) and a control intervention (normal school care). Each of the 60 schools will be randomly assigned to one of these two groups. Half of the schools (30) will receive the DISCOVER workshop and the other half (30) of schools will receive their normal care. We will assess participants' mood, stress levels and wellbeing before the intervention and at several points afterwards, in both the workshop and control groups. Following trial completion of all participants, we will then analyse this data to evaluate whether the workshop was more beneficial than the normal care students receive.

What are the possible benefits and risks of participating?
If you receive the workshop, it could help you handle stressful situations in a more helpful way, making it easier to tackle everyday problems. The DISCOVER workshop leaders will offer advice and help during the workshop and at the follow up session. However, the decision may be that your school/college will not be receiving the workshops. In which case, you will receive the normal help available from the school/college (e.g. access to websites, school counsellor). This will be helpful for us to know how students get on without receiving any extra help.

Participation does not have any likely risks associated with it. Sometimes, when we ask young people questions about their feelings, it can be mildly upsetting, but there will always be someone available for them to talk to and to provide any help needed.

Where is the study run from?
King's College London (UK). The study will be taking place in 4 sites; London, Bath, Manchester, and Northampton (London is the lead centre for the study). It will involve a total of 60 schools and 900 sixth form students.

When is the study starting and how long is it expected to run for?
January 2020 to April 2024

Who is funding the study?
National Institute for Health Research (NIHR) (UK)

Who is the main contact?
Dr Stephen Lisk, stephen.lisk@kcl.ac.uk
Dr June Brown, june.brown@kcl.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Stephen Lisk

ORCID ID

Contact details

King's College London
16 De Crespigny Park
Camberwell
London
SE5 8AF
United Kingdom
+44 (0)20 784 80715
stephen.lisk@kcl.ac.uk

Type

Public

Additional contact

Dr June Brown

ORCID ID

Contact details

King's College London
16 De Crespigny Park
Camberwell
London
SE5 8AF
United Kingdom
+44 (0)20 78485004
june.brown@kcl.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

NIHR127951

Study information

Scientific title

Brief Educational workshops in Secondary Schools Trial: a multi-centre cluster randomised controlled trial of self-referral psychological stress workshops in schools for depression and anxiety in 16-18 year-olds.

Acronym

BESST

Study hypothesis

1. Compared to those receiving a control intervention, participants receiving the DISCOVER workshop intervention will show greater reduction in symptoms of depression at 3 and 6 months
2. Compared to those receiving a control intervention, participants receiving the DISCOVER workshop intervention will show greater reduction in symptoms of anxiety at 3 and 6 months post-intervention
3. Compared to those receiving a control intervention, participants receiving the DISCOVER workshop intervention will show greater improvement in wellbeing at 3 and 6 months post-intervention
4. Cost-effectiveness of DISCOVER will be comparable to the control treatment in terms of quality adjusted life years (QALYs) at 3 and 6 months post-intervention?
5. The intervention will be considered acceptable by young people
6. What are the contextual (e.g. school) and process (e.g. workshop publicity) factors that influence implementation and clinical effectiveness?

Ethics approval

Approval pending. Submission for ethical approval with King's College London Research Ethics Committee will take place on 30th June 2020.

Study design

Two arm blinded (researchers, analyst) multi-centre cluster randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Schools

Trial type

Quality of life

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

Depression and anxiety

Intervention

Participants in the intervention arm will receive a one-day, school-based mental health programme called the DISCOVER workshop, administered by trained NHS practitioners.
Participants in the control arm will receive normal school provision and will be offered a brief leaflet signposting them to relevant local and web-based mental health resources.
Using an online randomisation system set up by the Kings Clinical Trials Unit (CTU), schools will be randomly assigned to the intervention or control arm (1:1 allocation ratio) after students have consented and baseline data has been collected.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Symptoms of depression, measured using the Mood and Feelings Questionnaire (MFQ), collected at baseline, and 3 and 6 months post-intervention

Secondary outcome measures

1. Symptoms of anxiety, measured using the Revised Child Anxiety and Depression Scale (RCADS), collected at baseline, and 3 and 6 months post-intervention
2. Wellbeing, measured using the Warwick Edinburgh Mental Wellbeing scale (WEMWBS), collected at baseline, and 3 and 6 months post-intervention
3. Cost-effectiveness, measured using the Child and Adolescent Service Use Schedule (CA-SUS), collected at baseline and 3 and 6 months post-intervention
4. Quality of life, measured using the EQ-5D-3L (a self-report measure of health-related quality of life, used to calculate quality-adjusted life years (QALYs) suitable for economic evaluation), collected at baseline, and 3 and 6 months post-intervention
5. Participant satisfaction, measured using the the Client Satisfaction Questionnaire, collected immediately post-intervention, and 3 and 6 months post-intervention
6. A qualitative process evaluation, designed to (a) examine the contextual and process factors that either support or obstruct the implementation of the intervention, (b) examine the experience of participants and workshop facilitators and (c) assess whether and how the contextual (e.g. school regime and environment) and process factors (e.g. publicity, component parts of the workshop) identified through this work influence the intermediary outcomes (e.g. engagement, intervention fidelity, adherence to intervention protocol) as well as the primary and secondary outcomes assessed in the trial. The qualitative process evaluation will be conducted in 8 intervention schools (following completing of follow-up measures), using semi-structured interviews (with n=16 students, n=8 workshop facilitators) and focus groups with school staff (n=8).

Overall trial start date

01/01/2020

Overall trial end date

01/04/2024

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Aged between 16 - 18 years
2. Enrolled at one of the schools taking part in the trial, with planned attendance until the end of the summer term
3. Sufficient English to provide valid informed consent and complete assessments
4. Be seeking help for stress (with or without teacher encouragement)
5. Able to attend and take part in the workshop

Participant type

Other

Age group

Mixed

Gender

Both

Target number of participants

900

Participant exclusion criteria

1. Identified as actively suicidal (through risk assessment)
2. Current involvement with Child and Adolescent Mental Health Services
3. Current involvement with school counselling
4. Severe learning difficulties or psychosis

Recruitment start date

01/09/2020

Recruitment end date

01/12/2022

Locations

Countries of recruitment

United Kingdom

Trial participating centre

King's College London
Institute of Psychiatry, Psychology and Neuroscience (IoPPN) 16 De Crespigny Park Camberwell
London
SE5 8AF
United Kingdom

Trial participating centre

The University of Manchester
Oxford Rd
Manchester
M13 9PL
United Kingdom

Trial participating centre

University of Bath
Claverton Down
Bath
BA2 7AY
United Kingdom

Trial participating centre

University of Northampton
Waterside Campus, University Drive
Northampton
NN1 5PH
United Kingdom

Sponsor information

Organisation

King's College London

Sponsor details

Research & Development Office
Institute of Psychiatry
Psychology and Neuroscience
16 De Crespigny Park
London
SE5 8AF
United Kingdom
+44 (0)20 7848 0790
slam-ioppn.research@kcl.ac.uk

Sponsor type

University/education

Website

http://www.kcl.ac.uk

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

We aim to publish our trial protocol in a peer reviewed open access journal (e.g. Trials) prior to the end of recruitment. We aim to publish our main trial findings in high impact, peer-reviewed, open access journals (e.g. Lancet, BMJ).

We will ensure that the trial outcome is known to clinicians and academics by presenting our findings at relevant national meetings (e.g. Association of Child and Adolescent Mental Health) and International Conferences (World Congress of Behavioural and Cognitive Therapy; European Association of Cognitive and Behavioural Therapy).

Results will be made available to all participants and presented to teachers after the completion of the study. Young Advisors, as part of DISCOVER PPI, will help draft the results in different styles and formats using different media (video-blogs, tweets) that will be accessible for young people and their carers. Wide service user and public audiences will access background information and reports through a designated project website, the contents and features of which will be co-produced by Young Advisors. We will also raise public awareness of our results through press releases, and the media.

We will share our results with policy makers through the Improving Access to Psychological Therapies Programme for Children and Young People (IAPT-CYP) which is a national training programme which oversees the development of CAMHS training in evidence-based interventions. We will also disseminate our findings to the Department for Education and Department of Health in relation to the new national Green Paper initiatives which detail plans for national level frameworks to train graduate mental health workers who specifically run interventions in schools. We will also disseminate our findings to schools and academies, and relevant education conferences, teacher training, clinical psychology training courses and CAMHS courses eg MSc in Child Mental Health at KCL.

With regard to publications in scientific journals, we aim to publish four papers:
I) Protocol
ii) Clinical effectiveness
iii) Economic evaluation
iv) Process evaluation

IPD sharing statement:
The current data sharing plans for this study are unknown and will be available at a later date.

Intention to publish date

01/09/2022

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

28/05/2020: Trial’s existence confirmed by NIHR HTA